" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
[Alpha1-Proteinase Inhibitor (Human)] for Injection
Zemaira is a sterile, white, lyophilized preparation of purified Alpha1-Proteinase Inhibitor (Human) (A1-PI), also known as alpha1-antitrypsin, to be reconstituted and administered by the intravenous route. The specific activity of Zemaira is ≥ 0.7 mg of functional A1-PI per milligram of total protein. The purity (total A1-PI/total protein) is ≥ 90% A1-PI. Each vial contains approximately 1000 mg of functionally active A1-PI. The measured amount per vial of functionally active A1-PI as determined by its capacity to neutralize human neutrophil elastase (NE) is printed on the vial label and carton. Following reconstitution with 20 mL of Sterile Water for Injection, USP, the Zemaira solution contains 73 to 89 mM sodium, 33 to 42 mM chloride, 15 to 20 mM phosphate, and 121 to 168 mM mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH. Zemaira contains no preservative.
All plasma used in the manufacture of Zemaira is obtained from US donors and is tested using serological assays for HBsAg and antibodies to HIV-½ and HCV. The plasma is tested with Nucleic Acid Testing (NAT) for HBV, HCV, HIV-1, and HAV, and found to be nonreactive (negative). The plasma is also tested by NAT for B19V. Only plasma that passed the virus screening is used for production. The limit for B19V in the fractionation pool is ≤ 104 International Units of B19V per mL.
Zemaira is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps. The manufacturing process includes two virus clearance steps: heat treatment at 60°C for 10 hours in an aqueous solution with stabilizers; and nanofiltration. These virus clearance steps have been validated in a series of in vitro experiments for their capacity to inactivate/ remove both enveloped and non-enveloped viruses. Table 5 shows the virus clearance capacity of the Zemaira manufacturing process, expressed as mean log10 reduction factor.
Table 5: Cumulative (Log10) Virus Inactivation/Removal
|Manufacturing Step||Virus Reduction Factor (Log10)|
|Enveloped Viruses||Non-Enveloped Viruses|
|Heat treatment*†||≥ 6.8||≥ 5.2||≥ 8.3||4.4||≥ 5.4||na|
|Nanofiltration||≥ 5.5||≥ 5.4||. ≥ 8.4||≥ 6.3||≥ 5.3||≥ 6.4|
|Cumulative Virus Reduction (log10)||≥ 12.3||≥ 10.6||≥ 16.7||≥ 10.7||≥ 10.7||≥ 6.4|
|HIV, human immunodeficiency virus type 1, a model for
HIV-1 and HIV-2.
BVDV, bovine viral diarrhea virus, a model for HCV.
WNV, West Nile virus.
PRV, pseudorabies virus, a non-specific model for large DNA viruses, eg. herpes.
HAV, hepatitis A virus.
CPV, canine parvovirus, model for B19V.
na, not applicable.
* Studies using B19V, which are considered experimental in nature, have demonstrated a virus reduction factor of 1.9 log10.
† At 60°C for 10 hours.
What are the possible side effects of alpha 1-proteinase inhibitor?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pain or burning when you urinate;
- wheezing, chest pain or tightness, trouble breathing; or
- vision changes.
Less serious side effects may...
Last reviewed on RxList: 3/18/2016
This monograph has been modified to include the generic and brand name in many instances.
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